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NCT Number: NCT06028165

CABG Based on CT-FFR Versus Conventional Coronary Angiography

The aims of study are (1) to compare early and 1-year graft patency rates in patients who underwent coronary artery bypass grafting (CABG) based on conventional coronary angiography(CAG) versus cardiac computed tomography(CT)-derived fractional flow reserve(FFR), and (2) to demonstrate difference in clinical outcomes between the 2 groups.

Recruiting

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Myongji Hospital

Goyang-si, Gyeonggi-do, South Korea

Location status: Recruiting

Location contact

Min-Seok Kim, MD, PhD, MSc

CONTACT

About this study

The CABG-COREA trial is designed as a randomized, controlled trial to recruit 96 patients who undergo coronary artery bypass grafting. Patients were randomized by use of a randomization table. Coronary arteries are revascularized based on conventional coronary angiography (quantitative coronary angiography) or cardiac computed tomography-derived fractional flow reserve according to the randomization result.

The primary end point is to evaluate early and 1-year postoperative graft patency. The secondary end points are overall survival, freedom from cardiac death and freedom from MACCE(major adverse cardiac or cerebrovascular events).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age equal or more than 40
  • age equal or less than 80
  • patients who undergo coronary artery bypass grafting due to multi-vessel coronary artery disease
  • patients who agree to the enrollment

Exclusion criteria

  • Patients with heart failure (left ventricular ejection fraction < 25%)
  • patients who have intractable ventricular arrhythmia
  • patients who has been treated for cancer
  • patients who has infectious disease
  • patients who are planned to undergo combined cardiac surgery
  • patients who has medical co-morbidity with expected survival less than 1 year
  • patients with a history of previous cardiac surgery
  • Patients with chronic renal failure requiring dialysis
  • patients who undergo emergency operation

Treatment and study plan

Coronary artery bypass grafting based on conventional coronary angiography

Procedure

Revascularized coronary arteries are decided based on conventional coronary angiography (quantitative coronary angiography)

Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.

Procedure

Revascularized coronary arteries are decided based on cardiac computed tomography-derived fractional flow reserve.

Primary outcomes

  1. 1-Year graft patency rates

    Time frame: 1 year

    postoperative graft patency measured by 1 year postoperative coronary angiography

Secondary outcomes

  1. Overall survival

    Time frame: 4 years

    Overall survival rate at 4 years

  2. Freedom from Cardiac Death

    Time frame: 4 years

    Freedom from cardiac death at 4 years

  3. Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)

    Time frame: 4 years

    freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years

  4. Early Angiographic Patency Rates

    Time frame: 1.5 days

    The patency rate of the grafts evaluated with coronary angiograms early after coronary artery bypass grafting

Study contacts

Contact information is provided by the study sponsor or research team.

Min-Seok Kim, MD, PhD, MSc

CONTACT

[email protected]

82-10-8482-0380

Sponsors and collaborators

Lead sponsor

Myongji Hospital

Other

Registry information

Official study title

A Prospective, Randomized Comparison of Coronary Artery Bypass Grafting Based on COmputed Tomography-derived Fractional Flow REserve Versus Angiography (CABG-COREA Trial)

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 8, 2023
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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